Kornimate/medical-research-clean huggingface dataset:
a study in healthy adult subjects to evaluate the safety, tolerability, and pharmacokinetic profiles of multiple doses of abt-072 used to treat hepatitis c

Conditions: HCV Infection

Summary: the purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of abt-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state abt-072 pharmacokinetics.

phase 1, blinded, randomized, placebo-controlled study in healthy adult subjects to evaluate the safety, tolerability, and pharmacokinetic profiles of multiple doses of abt-072

Eligibility criteria:
inclusion criteria: * main selection criteria for healthy volunteers: * subject has provided written consent. * subject is in general good health. * if female, subject is postmenopausal for at least 2 years or surgically sterile. * if female, subject is not pregnant and is not breast-feeding. * male or female between 18 and 55 years old, inclusive. * if male, subject must be surgically sterile or practicing at least 1 method of birth control. * body mass index (bmi) is 18 to 29, inclusive. exclusion criteria: * use of medications including over the counter and vitamines. * abuse of alcohol, drugs, or nicotine. * current diseases or disorders. * history of cardiac disease. * if after consideration by the investigator, for any reason, that you are unsuitable to receive abt-072.
cpvi alone versus cpvi plus low-voltage areas ablation during sr versus cpvi plus low-voltage areas ablation during af for the treatment of caf

Conditions: Atrial Fibrillation

Summary: the primary objective of this investigation is to compare the efficacy of three different af ablation strategies in patients with persistent atrial fibrillation: cpvi plus low-voltage areas ablation during sinus rhythm versus. cpvi plus low-voltage areas ablation during af and cpvi alone.


Eligibility criteria:
inclusion criteria: 1. patients age is 18-80 years; 2. patients with non-paroxysmal af; non-paroxysmal af will be defined as a sustained episode lasting \> 7 days; 3. patients can sign the written informed consent for the study; 4. patients can endure the required follow-up. exclusion criteria: 1. patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation 2. preoperative combined atrial tachycardia (≥30s) and atypical atrial flutter 3. left atrial diameter \>55mm 4. left ventricular ejection fraction \<35% 5. left atrial thrombus 6. postoperative cardiac surgery 7. after valve replacement 8. after permanent pacemaker implantation 9. hypertrophic cardiomyopathy 10. patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease 11. hemorrhagic stroke within 6 months 12. transient ischemic attack or ischemic stroke within 1 month 13. mental disorder or history of mental illness and inability to cooperate voluntarily 14. breastfeeding, pregnancy and women planning or likely to become pregnant 15. life expectancy \<12 months 16. participating in other interventional clinical trials 17. the researchers judged that it was not suitable for inclusion in this study
acute effects of nutrition supplementation on treatment efficiency and hemodynamics during dialysis

Conditions: Blood Pressure; Kidney Failure, Chronic; Dietary Modification

Summary: the purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.

the consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality. despite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the united states. the reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure bp or a reduced efficiency of solute removal following eating during hd treatment. an alternative to eating solid food is to provide patients with liquid nutritional supplements. clinics in the us are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.

Eligibility criteria:
inclusion criteria: * receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a nephrologists exclusion criteria: * milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week
study of ivc filter retrieval with the günther tulip vena cava filter

Conditions: Pulmonary Embolism; Venous Thromboembolism

Summary: the purpose of this study is to test the hypothesis that the günther tulip vena cava filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.


Eligibility criteria:
inclusion criteria: * patient must be considered at high risk for pe, but placement of a permanent ivc filter is not likely to be required. * patient must have a patent internal jugular vein. * patient has given informed consent. exclusion criteria: * patient is less than 18 years. * patient has a pre-existing filter * patient had indications for a permanent filter at the time of the initial evaluation. * patient has uncontrollable coagulopathy. * patient has a short life expectancy \< 6 months. * patient has metastatic malignancy. * patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters. * patient has a contrast allergy that cannot be adequately pre-medicated. * patient is at risk of septic embolism. * patient has sepsis. * patient has a hypersensitivity to any of the components of the gt filter, specifically cobalt, nickel, and chromium. * patient has impaired renal function (creatinine \> 2.0). * patient is pregnant or planning to become pregnant within the next 6 months

Keywords: pulmonary embolism venous thromboembolism inferior vena cava filter ivc pe
a long-term, open-label study to evaluate the safety of sitaxsentan sodium treatment in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with pah until sitaxsentan, in a particular country or region, is commercially available for the treatment of pah or the study is closed.

open-label extension

Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary arterial hypertension (pah) confirmed by cardiac catheterization. * current diagnosis of who group 1 pah with functional class 2, 3, or 4 symptoms. exclusion criteria: * has portal hypertension or chronic liver disease. * has history of left sided heart disease or significant cardiac disease.

Keywords: open-label study
pain after laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: to the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. the investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane. purpose to find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.


Eligibility criteria:
inclusion criteria: 1. patient ages 18-64 2. american society of anesthesiology physical status i, ii or iii 3. inpatients scheduled to undergo laparoscopic cholecystectomy at ben taub general hospital exclusion criteria: 1. open cholecystectomy - excluded due to increased levels of pain in open procedures 2. scheduled for ambulatory surgery 3. renal dysfunction (serum cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications 4. allergy to any of the study medications or anesthetic agents 5. chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone 6. patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder) 7. patient or surgeon refusal
study of tj033721 (givastomig) in subjects with advanced or metastatic solid tumors

Conditions: Solid Tumor; Advanced Cancer; Metastatic Cancer; Gastric Cancer; Gastroesophageal Junction Carcinoma; Esophageal Adenocarcinoma

Summary: this is an open label, multi-center, multiple dose phase 1 study to evaluate the safety, tolerability, mtd pk, and pd of tj033721 (givastomig) in subjects with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: part 1 - monotherapy • subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. part 2 - combination therapy subjects with treatment naïve locally advanced, unresectable or metastatic gastric, gej, esophageal adenocarcinoma; * eastern cooperative oncology group (ecog) performance status 0 or 1 with adequate organ function * have known pd-l1 status with prior testing by immunohistochemistry and a corresponding combined positive score (cps) for dose expansion and part 2 combination subjects: • must have cldn18.2-positive tumor expression exclusion criteria * prior exposure to cldn18.2 -targeted therapy * prior exposure to 4-1bb agonists * second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ * known active or chronic hepatitis b or hepatitis c, other hepatitides * unstable/active ulcer or digestive tract bleeding within 6 weeks * active autoimmune disease requiring systemic treatment within the past 2 years * active interstitial lung disease (ild) or pneumonitis or a history of ild or pneumonitis requiring treatment * known active cns metastases and/or carcinomatous meningitis. subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment; * new york heart association (nyha) class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (mi), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (tia), arterial embolism, percutaneous transluminal coronary angioplasty (ptca), or coronary artery bypass grafting (cabg) in the previous 6 months * diagnosis of immunodeficiency such as known active hiv * any active infection requiring parenteral treatment for part 2 combination subjects: • prior treatment with anti-pd-1 or pd-l1
registry branch gore endoprosthesis

Conditions: Aortic Aneurysm, Thoracic; Aortic Dissection

Summary: multicenter registry on patients treated by the new gore thoracic branched endoprosthesis

this is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the gore thoracic branched endoprosthesis. inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.

Eligibility criteria:
inclusion criteria: * patients receving the gore tag thoracic branched endograft for thoracic aorta pathologies exclusion criteria: * less than 18 years * allergy to endograft components * patients receiving other types of arch endografts

Keywords: endograft
a clinical study to evaluate the clinical performance and safety of liquiband fix8® versus absorbatack™ for hernia mesh fixation and peritoneal closure in groin hernia repair

Conditions: Hernia; Inguinal Hernia; Femoral Hernia; Groin Hernia

Summary: this is a multi-center, randomized controlled trial of 284 subjects (142 in each group). patients will be blinded to the fixation method used. the objective of this study is to compare the efficacy and safety of the liquiband fix8® device to the tack-based control device (absorbatack™) for laparoscopic groin hernia (inguinal or femoral) repair. the primary outcome measure is an improvement in pain score measured by vas at 6 months. secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (carolina comfort scale).


Eligibility criteria:
inclusion criteria: is male or female, ≥22 years of age is willing and able to give written informed consent has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral) is currently scheduled and eligible for tapp or tep laparoscopic groin hernia repair (inguinal or femoral) hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following; * 3d max™ mesh (bard inc.) * 3d max™ light (bard inc.) * parietex™ 2d (order code starting with tec) flat sheet mesh (medtronic) * parietex™ 3d (order code starting with tet) flat sheet mesh (medtronic) is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period exclusion criteria: has a hernia type not suitable for laparoscopic hernia repair as determined by the investigator (i.e. strangulated) subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the investigator prevents access to the pre-peritoneal space for tapp or tep laparoscopic hernia repair is pregnant or actively breastfeeding has a known sensitivity to cyanoacrylate or formaldehyde,d\&c violet no.2 dye or any component of liquiband fix8® or control device has an active or potential infection at the surgical site or systemic sepsis hernia mesh to be used at surgery is less than 4"x6" in size, or not one of the types of mesh listed in inclusion criteria above cannot tolerate general anaesthesia has any significant or unstable medical or psychiatric condition that, in the opinion of the investigator, would interfere with his/her ability to participate in the study

Keywords: laparoacopic peritoneal closure
strength training following gastric bypass for obesity

Conditions: Obesity

Summary: we will assess whether undesirable loss of lean tissue following gastric bypass surgery for obesity can be minimized by protein supplementation and exercise training.


Eligibility criteria:
* clinically severe obesity * candidate for bypass surgery * new york city local address * willing to visit hospital weekly

Keywords: obesity gastric bypass obesity surgery bariatric surgery exercise
evaluation of a training for healthcare providers in supporting men experiencing suicidal ideation

Conditions: Suicide; Suicidal Ideation

Summary: the primary objective of this study is to assess how healthcare providers perceive and evaluate the developed e-learning. the findings will inform potential adjustments to enhance the e-learning as needed.

in a previous study (bun: b6702024000090), the authors focused on identifying barriers and needs among adult men experiencing suicidal thoughts and their healthcare providers. findings from this needs assessment indicate a demand for a training (e-learning) to equip healthcare providers with strategies for working effectively with men experiencing suicidal ideation. additionally, the assessment among individuals with suicidal ideation identified several key recommendations and considerations which healthcare providers should incorporate into their practice. therefore, an e-learning was developed with integrated psycho-education and the primary objective of this study is to assess how healthcare providers perceive and evaluate the developed e-learning. the findings will inform potential adjustments to enhance the e-learning as needed. participants will be recruited through announcements on the flemish suicide prevention portal website (www.zelfmoord1813.be) and websites of relevant partners (i.e. vvkp, vvp, gezond leven, psyché, vivel, logo's, cgg-sp, domus medica,...), as well as via social media (mainly linkedin, instagram and facebook) and newsletters of the flemish centre of expertise in suicide prevention and its relevant partner organizations. individuals interested in participating will be directed to register online through redcap, where they will review and approve an informed consent form.after providing informed consent, participants will be asked to provide their email address. the email address will be used solely for the following purposes: - sending a reminder to complete the post-test questionnaire three days later. once consent is provided, participants will be directed to the online pre-test questionnaire (see table 1), which takes approximately 10 minutes to complete. following the pre-test, participants will be directed to the e-learning module, which requires 30-60 minutes. at the end of the e-learning, healthcare providers will be asked to complete the post-test questionnaire, which is estimated to take 15 minutes. in case a participant does not complete the post-test, a reminder will be sent via e-mail three days later.

Eligibility criteria:
inclusion criteria: * healthcare providers (e.g. gp's, psychiatrists, medical doctors, psychologists, psychotherapists, and nurses working in healthcare) * ≥18y/o * access to a smartphone, tablet, or computer with internet connection and proficiency in dutch exclusion criteria: * does not meet the specified inclusion criteria.
cyberknife ultra-hypofractionated sbrt for localized prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective observational study. the study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (uh) cyberknife stereotactic body radiation therapy treatment on the whole prostate gland plus simultaneous integrated boost (sib) to the dominant intraprostatic lesions (dil(s) in intermediate-unfavourable to high-risk prostate cancer (pca) patients.

the patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of prostate specific antigen (psa) and testosterone analysis, uroflowmetry and multiparametric magnetic resonance imaging (mpmri) are mandatory if not already done. additional staging imaging (computed tomography (ct) and/or bone scan) will be required according to national comprehensive cancer network (nccn) category risk group. subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland. ct with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; cyberknife-stereotactic body radiation therapy (sbrt) treatment will start after 5-7 days from the simulation ct. a total of 36.25 gy to the prostate gland will be executed in 5 alternate days. for each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. finally, in the last treatment day qol and both clinician- and patient-reported genitourinary (gu) and gastrointestinal (gi) acute toxicity assessment is required.

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 80 years * histologically confirmed adenocarcinoma of the prostate * low, intermediate and high-risk category according to nccn version 02.2021 * clinically node negative and no distant metastasis * eastern cooperative oncology group (ecog) performance status \<2 * good urinary flow (peak flow \>10 ml/s) or ipss \< 15 * prostate volume \< 100 cc * available mpmri of the prostate * less than 3 dils at mpmri (if \>2 dils, only dils with higher prostate imaging - reporting and data system (pirads) will be included and only pi-rads \>2) * written informed consent for treatment and research purpose exclusion criteria: * platelets count \< 75000 * urethral stricture * previous pelvic rt * concomitant inflammatory bowel disease or other serious systemic comorbidities * previous prostatectomy * presence of hip prosthesis
pep005 gel - biological effects in actinic keratosis assessed by reflectance confocal microscopy

Conditions: Actinic Keratosis

Summary: this trial will be conducted to explore the biological effects in the skin following treatment with pep005 gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.


Eligibility criteria:
inclusion criteria: 1. male or female subjects at least 18 years of age 2. subjects with ak lesions and subclinical ak lesions within a contiguous 25 cm2 area on the upper extremity 3. subjects must have a 25 cm2 area of normal skin on the inner upper arm 4. female subjects must be of either:• non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • childbearing potential, with a confirmed negative urine pregnancy test prior to exposure. 5. female subjects of childbearing potential must be willing to consent to using high effective methods of contraception 6. ability to follow trial instructions and likely to complete all trial requirements 7. obtained written informed consent prior to any trial-related procedures exclusion criteria: 1. location of the selected treatment areas:• within 5 cm of an incompletely healed wound or infected area of the skin • within 10 cm of a suspected basal cell carcinoma (bcc) or squamous cell carcinoma(scc) 2. history or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product 3. clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant ae or interfere with assessments of safety during the course of the trial, as determined by investigator clinical judgment 4. anticipated need for in-patient hospitalisation or in-patient surgery during the trial period. 5. current participation in any other interventional clinical trial 6. subjects who have received treatment with any non-marketed drug product within the last two months 7. previous enrolment in this clinical trial 8. prohibited therapies and/or medications 2 weeks prior to the screening visit within 2 cm of selected treatment area:•cosmetic or therapeutic procedures •use of acid-containing therapeutic products • use of topical salves or topical steroids 9. prohibited therapies and/or medications: within 4 weeks prior to the screening visit: • treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with uvb 10. prohibited therapies and/or medications: within 8 weeks prior to the screening visit: • treatment with 5-fu, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas. 11. use of systemic retinoids